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Sanofi Reports Positive Data for Atopic Dermatitis Drug

[ Price : $8.95]

Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-s...

FDA OKs Guardant360 CDx Companion Diagnostic

[ Price : $8.95]

FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant m...

FDA Reports Gains in Drug Inspection Program

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FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong perf...

Testing Deficiencies Cited at Asahi Kasei Finechem API Plant

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FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the companys ac...

FDA Highlights Expedited Pathways in Drug Approval Report

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FDAs annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathwa...

Sato Pharmaceutical FDA-483 Out

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FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufact...

FDA Drug Ad Enforcement Letters Hit 25-Year High

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Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 20...

Corcept Reports Promising Survival Data for Ovarian Cancer Drug

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As its NDA is currently under FDA review, Corcept Therapeutics says its experimental drug relacorilant met the overall survival pr...

6 Observations in Lupin Nagpur Inspection

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FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, Indi...

Draft Guide on Blood Pressure Monitoring Sensors

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FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices shou...